Sientra Post-Approval Study

Tiger Biosciences, LLC.5,498 enrolled

Overview

This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.

Study Type

OBSERVATIONAL

Enrollment

5,498

Conditions

Breast Augmentation Breast Reconstruction Breast Revision

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Genetic female with US residency 2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation 3. Agrees to Sientra study requirements Exclusion Criteria: 1. Has an active infection anywhere in body 2. Has active cancer without adequate treatment 3. Currently pregnant or nursing 4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements 5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

Locations (1)

Sientra, Inc.

Santa Barbara, California, United States

Outcomes

Primary Outcomes

Long-term safety of Sientra Silicone Gel Breast Implants in women

Time frame: 10-years

Data from ClinicalTrials.gov

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